SEC, FDA sign info-sharing agreement as a ‘signal to the market’ on insider trading

Special report: Meet the 2026 Fierce 50 Biotech SEC, FDA sign info-sharing agreement as a ‘signal to the market’ on insider trading By Will Maddox Sep 2, 2026 10:15am SEC FDA clinical trials insider trading The SEC and the FDA have signed a three-year agreement to step up cooperation and information-sharing capabilities aiming to improve each organization’s regulatory and enforcement missions. The memorandum of understanding (MOU) between the two federal agencies “aims to enhance both parties’ ability to carry out their respective missions of protecting the public health and ensuring the integrity of the financial markets,” according to the MOU shared this week. “FDA-related disclosures by public companies have a significant impact on our markets,” said SEC Chairman Paul S.

Atkins in the release. “The FDA is a valuable partner in our efforts to administer and enforce applicable disclosure requirements under the federal securities laws, and I look forward to further strengthening our partnership through the MOU.” In an effort to maintain the integrity of the public markets and enforce insider trading violations, the SEC reviews disclosures and financial statements of all public companies, including organizations engaged in FDA-regulated activities like clinical trials and drug approvals. If a company disseminates false or misleading statements to the public connected to the FDA, or an insider uses information to improperly benefit in the public markets, the MOU will allow the SEC’s investigation to be more efficient.

The MOU details an agreement under which each organization would create an efficient mechanism to send information requests and share non-public information. It also mandates a point of contact to facilitate the exchange. Pillsbury Partner David Oliwenstein, who is a former senior counsel in the market abuse unit of the SEC’s Division of Enforcement, now focuses on corporate defense and white collar investigations.

Given his experience on both sides of SEC insider trading investigations, he told Fierce that the MOU is “a potential tool to help the SEC garner real-time information from the FDA about drug trials and other information, so that the SEC staff can compare it with what biopharma companies are telling their investors.” He noted that the MOU likely has three main goals. First, it is to broadcast to the industry that the SEC intends to keep a close eye on biopharma insider trading. “Biopharma has always been a space that the SEC enforcement staff has focused on in relation to insider trading in advance of clinical trials,” he said.

“The existence of this MOU is designed to signal to the market that the SEC is closely watching this space, and this is designed to act as an additional deterrent to misuse of confidential clinical trial information,” he said. Additionally, Oliwenstein noted that the volume and technical nature of clinical trial data present unique hurdles to the SEC staff when investigating, and the agreement will allow more communication between the organizations that will make investigations more efficient. “Streamlining our information-sharing helps protect both the patients who rely on FDA-regulated products and the public trust that drives healthcare innovation,” said Acting FDA Commissioner Kyle Diamantas in the release.

Finally, Oliwenstein said the MOU was likely put in place because biopharma is already an industry ripe for insider trading abuse. “The enforcement staff that's responsible for insider trading surveillance thinks that this is an area where there's a lot of misconduct,” he said. While the SEC already had the ability to access FDA information and interview company executives and others involved in trials when investigating, the MOU will streamline the process and improve the exchange of data between the organizations.

“It would function as an additional source of leads to start investigations, but also as an additional check on information that the SEC may be reviewing in public filings or receiving from companies about the status of clinical trials,” Oliwenstein said. With the rise of biopharma in prediction markets complicating the federal government’s ability to regulate improper use of inside information, the SEC is staying focused on the industry. “In an era in which enforcement in other areas has trailed off a bit, this is an area where the government continues to focus,” Oliwenstein said.

SEC FDA clinical trials insider trading Biotech